TYLOPLUS inj

COMPOSITION

Each mL of product contains 300 mg of Tilmicosin (as Tilmicosin phosphate)

TARGET SPECIES

Cattle and sheep

INDICATIONS

Cattle - Treatment of cattle respiratory diseases associated with Mannheimia haemolitica and Pasteurella mutocida. Treatment of interdigital necrobacillosis.

Sheep- Treatment of respiratory tract infections associated with Mannheimia haemolitica and Pasteurella mutocida. Treatment of pododermatitis in sheep caused by Dichelobacter nodosus and Fusobacterium necrophorum. Treatment of acute sheep mastitis caused by Staphylococcus aureus and Mycoplasma agalactiae.

CONTRAINDICATIONS

Do not administer intravenously. Do not administer intramuscularly. Do not administer to lambs weighing less than 15 kg. Do not administer to primates. Do not administer to pigs. Do not administer to horses and donkeys. Do not administer to goats.

ADVERSE REACTIONS

Occasionally, a slight diffuse inflammation may occur at the injection site, but it disappears within 5 to 8 days. In rare cases, decubitus, lack of coordination and convulsions were observed. Cattle death was observed after a single intravenous dose of 5 mg/kg body weight and after subcutaneous injection of 150 mg/kg body weight at 72-hour intervals. In pigs, intramuscular injection of 20 mg/kg body weight caused death. Sheep died after a single intravenous injection of 7.5 mg/kg body weight.

DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION

Only for subcutaneous injection. Use 10 mg tilmicosin per kg of body weight (corresponding to 1 mL of Tyloplus inj 300 mg/mL per 30 kg of body weight).

Cattle - Method of administration:

Take the necessary dose from the vial and remove the syringe from the needle, leaving the needle in the vial. When treating a group of animals, leave the needle in the vial to remove subsequent doses. Immobilise the animal and insert the needle separately subcutaneously at the injection site, preferably in the skin fold above the chest, behind the shoulder. Attach the syringe to the needle and inject at the base of the skin fold. Do not inject more than 20 mL at a single site of injection.

Sheep - Method of administration:

Precise weighing of lambs is important to avoid overdosing. Using a 2 mL or less syringe improves accurate dosing. Take the necessary dose from the vial and remove the syringe from the needle, leaving the needle in the vial. 

Immobilise the sheep and insert the needle separately subcutaneously at the injection site, which should be in the skin fold above the chest, behind the shoulder. 

Attach the syringe to the needle and inject at the base of the skin fold. 

Do not inject more than 2 mL at a single site of injection. 

If no improvement is observed within 48 hours, the diagnosis should be confirmed.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

Avoid the introduction of contaminants into the vial during use. The vial should be visually inspected to detect any foreign particles and/or an abnormal physical appearance. If any of these are observed, discard the vial.

WITHDRAWAL PERIOD(S)

Cattle - Meat and offal: 70 days. Milk: 36 days

If the product is administered to cows during dry periods or pregnant heifers (according to section 4.7 of the SmPC), the milk shall not be used for human consumption for 36 days after calving.

Sheep - Meat and offal: 42 days. Milk: 18 days

If the product is administered to sheep during dry periods or pregnant sheep (according to section 4.7 of the SmPC), the milk shall not be used for human consumption for 18 days after lambing.

SHELF LIFE

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf-life after first opening the immediate packaging: 28 days.

SPECIAL PRECAUTIONS FOR STORAGE

Keep out of reach of children. Do not store above 25°C. Do not refrigerate. Do not freeze. Do not expose to direct sunlight.

SPECIAL WARNING(S)

Sheep - Clinical trials have not demonstrated bacteriological healing in sheep with acute mamitis caused by Staphylococcus aureus and Mycoplasma agalactiae.

Do not administer to lambs weighing less than 15 kg, as there is a risk of overdose-related toxicity. Precise weighing of lambs is important to avoid overdosing. Using a 2 mL or less syringe helps accurate dosing.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

Official, national and regional antimicrobial policies must be taken into account when using the product. To avoid self-injection, do not use automated injection equipment. Where possible, the use of the product should be based on a susceptibility test.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT:

TILMICOSIN INJECTION IN PEOPLE MAY BE FATAL. ACT WITH EXTREME CAUTION TO AVOID ACCIDENTAL SELF-INJECTION AND FOLLOW EXACTLY THE ADMINISTRATION INSTRUCTIONS AND RECOMMENDATIONS BELOW.

This product should only be administered by a vet.

Never carry a syringe loaded with Tyloplus inj 300 mg/mL with the attached needle. The needle should only be connected to the syringe when filling the syringe or administering the injection. At any other time, keep the syringe separate from the needle.

Do not use automatic injection equipment.

Ensure that animals are properly immobilised, including those nearby.

Do not act alone when administering Tyloplus inj 300 mg/mL.

In case of self-injection IMMEDIATELY SEEK MEDICAL ASSISTANCE and take the vial or the package leaflet with you. Apply a cold compression (notice directly) to the injection site.

Avoid contact with skin and eyes. Rinse immediately with water any splashes on skin or into eyes.

It may cause sensitisation by skin contact. Wash your hands after use.

NOTE FOR PHYSICIANS

TILMICOSIN INJECTION IN PEOPLE IS ASSOCIATED WITH DEATH.

The cardiovascular system is the target of toxicity, and this toxicity can be caused by the calcium channel blockage. Intravenous calcium chloride administration should only be considered if there is a positive confirmation of exposure to tilmicosin.

In studies on dogs, tilmicosin induced a negative inotropic effect that led to tachycardia, as well as a reduction in systemic blood pressure and arterial pulse.

DO NOT ADMINISTER ADRENALINE OR BETA-ADRENERGIC ANTAGONISTS, SUCH AS PROPRANOLOL.

In pigs, tilmicosin-induced lethality is enhanced by adrenaline.

In dogs, IV calcium chloride treatment has shown a positive effect on the left ventricular inotropic status and some improvements in vascular blood pressure and tachycardia.

Preclinical data and an isolated clinical report suggest that calcium chloride perfusion may help reverse tilmicosin-induced changes in human blood pressure and heart rate.

Administration of dobutamine should also be considered due to its positive inotropic effects although it does not affect tachycardia. Since tilmicosin persists in tissues for several days, the cardiovascular system should be closely monitored and supportive care should be provided.

Physicians treating patients exposed to this compound are recommended to discuss clinical management with the National Poison Information Service within the National Public Health Institute - Toxicology Centre at: +40(0)213183606.

USE DURING PREGNANCY AND LACTATION 

The safety of the veterinary medicinal product has not been established during gestation.

Use only in accordance with the benefit/risk ratio evaluation performed by a competent veterinarian.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

In some species, interactions between macrolides and ionophores can be observed.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

In cattle, subcutaneous injections of 10, 30, 50 mg/kg body weight, repeated 3 times within 72 hours, did not cause death.

Doses of 150 mg/kg body weight administered subcutaneously within 72 hours caused death. Swelling was observed at the injection site, and at autopsy, the only identified lesion was mild necrosis of the myocardium. Other symptoms were: difficulty moving, decreased appetite and tachycardia.

In sheep, single injections (approximately 30 mg/kg body weight) can cause a slight increase in breathing rate. Higher doses (150 mg/kg body weight) caused ataxia, lethargy, and incapacity to lift the head.

Deaths occurred after a single intravenous injection of 5 mg/kg body weight in cattle and 7.5 mg/kg body weight in sheep.

INCOMPATIBILITIES

In the absence of compatibility studies, this product shall not be administered mixed with other veterinary medicinal products.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY. 

Any unused veterinary medicinal product or waste materials derived from such products should be disposed of in accordance with local requirements. The veterinary medicinal product should not be disposed of via waste water or sewage system.

PRESENTATION/PACKAGE

50mL; 100mL; 250mL polypropylene vials sealed with bromobutyl rubber stopper and aluminium cap.